A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The incumbent provides an independent review or audit of data, processes and reports for the assigned audit scope. Leads others in the interpretation of the regulations, and applicable protocols and SOPs.
Incumbent performs audits in a scope defined by the supervisor (e.g. genetic toxicology, mammalian toxicology). Understands and interprets the applicable regulations and possesses basic scientific knowledge of the audit scope. Provides guidance in regulatory interpretation to operations and Quality Assurance.
ESSENTIAL JOB FUNCTIONS
- Excellent background and understanding of GLP compliance and familiarity with all aspects of FDA, EPA and applicable international regulations.
- Excellent understanding of complex and evolving regulatory requirements and intent.
- Assure the protocol requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies to evaluate regulatory compliance.
- Plan, conduct and report study-specific laboratory inspections to assess compliance with GLP regulations/industry standards.
- Assure QA departmental inspection reports and any other supporting documentation or required records are appropriately processed and eventually archived, as appropriate.
- Identify regulatory compliance issues and provide regulatory support to departments.
- Constructively interact and communicate with employees in various settings.
- An understanding of laboratory quality assurance principles to ISO 17025 and their application as specified in the Quality Manual
- Keep QAU and QA Management apprised of compliance issues through frequent updates.
EXPANDED JOB FUNCTIONS
- Independently host client visits and regulatory inspections.
- Serve as a Liaison with operations departments to support consistent practice and advice.
- Lead and assist in planning facility audits.
- Perform vendor/subcontractor audits.
- Provide training and guidance to QAU personnel and others as needed.
- Assist in the planning, development, and delivery of comprehensive GLP Training Programs as needed.
- Able to audit in multiple disciplines (genetic toxicology, mammalian toxicology, AHS).
- Lead and participate in departmental business, process, or general regulatory projects
Who You Are
- Education: Bachelor’s Degree in a science field preferred (experience may be considered in lieu of a degree)
- Working knowledge of a research laboratory
- Experience auditing in a GLP or GMP facility (prefer min 4 years)
- Proven experience in conducting detailed external and internal audits, desirable.
- RQAP-GLP, or other applicable certification or registration desirable.
- Supervisory experience desirable.
- Knowledge and Skills:
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
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